Cervical PainNCT06257992
Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical Pain
A study testing Dry Needling and Stretch in people with Cervical Pain, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Dry Needling and Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2024to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be older than 18 years old
- Sign informed consent form prior to participating in this study
- Have chronic cervical pain diagnosis of their primary care doctor.
- Have one or more active myofascial trigger point in the cervical muscles according to the criteria established by Simons et al.
Who cannot join
- Major trauma on cervical spine stated from the medical history
- Inflammatory, hormonal or neurological disorders
- Have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia)
- Having received physiotherapy treatment for the condition in the past month
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Clínico de Fisioterapia OMT-E
Zaragoza, 50009
Jesús Marcen
+34644161870, info@centroclinicoomt.es
About this study
Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain.
- Conditions
- Cervical Pain
- Being tested
- Dry Needling, Stretch
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
3 treatments of dry needling to inactivate all active trigger points found in patient's cervical muscles.
StretchOther
3 treatments of stretch applied to all cervical muscles that present active trigger points in patient's cervical muscles.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | Not described Receives: Other: Dry Needling |
| Stretch Group | Active comparator | Not described Receives: Other: Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Pain Intensity
For the Assesment of cervical pain intensity the Numeric Pain Rating Scale (NPRS) was used.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Neck Disability Index
For the assesment of perceived neck disability the neck disability index was used.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Pressure Pain Threshold
For the assesment of pressure pain threshold of active trigger points a digital algometer was used
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Secondary outcomes (2)
Cervical range of movement
For the assesment of cervical range of movement the universal goniometer was used
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Cervical muscles Electromyography
For the assesment of cervical muscles electromyographic activity Trigno Avanti sensor was used.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Müller-Thyssen Uriarte, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257992
- Sponsor's protocol ID
- RAT 2022-53
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.
PubMed 27537209Fernandez-de-las-Penas C, Alonso-Blanco C, Miangolarra JC. Myofascial trigger points in subjects presenting with mechanical neck pain: a blinded, controlled study. Man Ther. 2007 Feb;12(1):29-33. doi: 10.1016/j.math.2006.02.002.
PubMed 21882489Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Fernandez-de-Las-Penas C, Martin-Casas P, Plaza-Manzano G. Dry Needling Versus Trigger Point Injection for Neck Pain Symptoms Associated with Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Pain Med. 2022 Mar 2;23(3):515-525. doi: 10.1093/pm/pnab188.
PubMed 34114639Ball AM, Finnegan M, Koppenhaver S, Freres W, Dommerholt J, Mayoral Del Moral O, Bron C, Moore R, Ball EE, Gaffney EE. The relative risk to the femoral nerve as a function of patient positioning: potential implications for trigger point dry needling of the iliacus muscle. J Man Manip Ther. 2019 Jul;27(3):162-171. doi: 10.1080/10669817.2019.1568699. Epub 2019 Feb 20.
PubMed 30935326
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical Pain
- ClinicalTrials.gov ID
- NCT06257992
- Acronym / sponsor ID
- RAT 2022-53
- Conditions
- Cervical Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Other: Dry Needling |
| Stretch Group | Active comparator | Other: Stretch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be older than 18 years old
- Sign informed consent form prior to participating in this study
- Have chronic cervical pain diagnosis of their primary care doctor.
- Have one or more active myofascial trigger point in the cervical muscles according to the criteria established by Simons et al.
Key exclusion criteria (4 listed)
- Major trauma on cervical spine stated from the medical history
- Inflammatory, hormonal or neurological disorders
- Have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia)
- Having received physiotherapy treatment for the condition in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Needling3 treatments of dry needling to inactivate all active trigger points found in patient's cervical muscles. | Other | Dry Needling Group |
| Stretch3 treatments of stretch applied to all cervical muscles that present active trigger points in patient's cervical muscles. | Other | Stretch Group |
Primary outcome
Cervical Pain Intensity
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
For the Assesment of cervical pain intensity the Numeric Pain Rating Scale (NPRS) was used.
Neck Disability Index
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
For the assesment of perceived neck disability the neck disability index was used.
Pressure Pain Threshold
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
For the assesment of pressure pain threshold of active trigger points a digital algometer was used
2 secondary outcomes
Cervical range of movement
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Cervical muscles Electromyography
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 27537209Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.
- Background: PubMed 21882489Fernandez-de-las-Penas C, Alonso-Blanco C, Miangolarra JC. Myofascial trigger points in subjects presenting with mechanical neck pain: a blinded, controlled study. Man Ther. 2007 Feb;12(1):29-33. doi: 10.1016/j.math.2006.02.002.
- Background: PubMed 34114639Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Fernandez-de-Las-Penas C, Martin-Casas P, Plaza-Manzano G. Dry Needling Versus Trigger Point Injection for Neck Pain Symptoms Associated with Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Pain Med. 2022 Mar 2;23(3):515-525. doi: 10.1093/pm/pnab188.
- Background: PubMed 30935326Ball AM, Finnegan M, Koppenhaver S, Freres W, Dommerholt J, Mayoral Del Moral O, Bron C, Moore R, Ball EE, Gaffney EE. The relative risk to the femoral nerve as a function of patient positioning: potential implications for trigger point dry needling of the iliacus muscle. J Man Manip Ther. 2019 Jul;27(3):162-171. doi: 10.1080/10669817.2019.1568699. Epub 2019 Feb 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Stretch in people with Cervical Pain, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Müller-Thyssen Uriarte (+34 0633673021, julianmuller.jmt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Pain Intensity (time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257992, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.